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510(k) K001974

EZ-ON CONDOM by Mayer Laboratories — Product Code MOL

K001974 is an FDA 510(k) premarket notification submitted by Mayer Laboratories for the device "EZ-ON CONDOM". The FDA issued a decision of Substantially Equivalent on October 24, 2001. The device falls under product code MOL (Condom, Synthetic), a Class II device regulated under 21 CFR 884.5300. Mayer Laboratories has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 24, 2001
Date Received
June 29, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Condom, Synthetic
Device Class
Class II
Regulation Number
884.5300
Review Panel
OB
Submission Type

Other clearances by Mayer Laboratories

  • K252158 — Sagami Original 002 Polyurethane Male Condom (March 30, 2026)
  • K130345 — AQUA LUBE NATURAL LUBRICANT - REGULAR, WARMING (August 1, 2013)
  • K113686 — KIMONO MICROTHIN WITH AQUA LUBE, REALITY ULTRA LUBRICATED (March 6, 2012)
  • K110325 — AQUA LUBE (December 8, 2011)
  • K946374 — KIMONO MICROTHIN (November 8, 1995)
  • K946376 — MAXX (September 22, 1995)
  • K943064 — KIMONO (CONDOMS) (September 22, 1995)
  • K925869 — SHEATHES, STERILE SHEATHES (January 6, 1994)
  • K926049 — DIGITEX, DIGITEX HYPOALLERGENIC (July 22, 1993)
  • K904375 — KIMONO PLUS (November 26, 1990)

Other clearances for product code MOL

  • K252158 — Sagami Original 002 Polyurethane Male Condom (March 30, 2026)
  • K243967 — ONE Nitrile Condom (April 8, 2025)
  • K241617 — Durex Polyisoprene Condom (February 28, 2025)
  • K240379 — TROJAN SIS Synthetic Latex Condom with Silicone Lubricant (October 8, 2024)
  • K240896 — ONE Nitrile Condom (August 23, 2024)
  • K232470 — Polyisoprene Extra Large Condom (May 9, 2024)
  • K231908 — 45 Micron Polyisoprene Condom (October 27, 2023)
  • K203541 — Okamoto 002 Lubricated Polyurethane Male Condom (February 25, 2022)
  • K182438 — Synthetic Polyisoprene Lubricated Male Condom - 5 senses (December 6, 2018)
  • K171172 — Skyn Original Polyisoprene Lubricated Male Condom - Flavored (August 2, 2017)

FDA data resources